Hyperion Therapeutics Inc reports extension of PDUFA action date for Ravicti NDA to 23 January 2013.
M2 PHARMA-September 6, 2012-Hyperion Therapeutics Inc reports extension of PDUFA action date for Ravicti NDA to 23 January 2013(C)2012 M2 COMMUNICATIONS
Biopharmaceutical company Hyperion Therapeutics Inc (NasdaqGM:HPTX) said on Wednesday that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for its New Drug Application (NDA) for Ravicti by three months.
The PDUFA action date for its NDA for Ravicti (glycerol phenylbutyrate) has been extended to 23 January 2013 to enable FDA to review additional solicited analyses of the company's existing clinical information.
According to the company, Ravicti, an investigational drug, is a pre-pro-drug of phenylacetic acid, the active moiety of BUPHENYL, the only branded therapy currently FDA-approved as adjunctive therapy for the chronic management of patients with the most prevalent urea cycle disorders.
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|Date:||Sep 6, 2012|
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